Use of a Rapid Turnaround Test for NG/CT to Improve Treatment of Women Presenting With Possible STIs
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ClinicalTrials.gov Identifier: NCT03098394 |
Recruitment Status :
Recruiting
First Posted : March 31, 2017
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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Sexually Transmitted Infection Gonorrhea Female Chlamydia Females | Device: Cepheid Xpert CT/NG Rapid Turnaround Test Device: Polymerase chain reaction (PCR) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a prospective, non-blinded, randomized clinical control trial |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in. |
Primary Purpose: | Diagnostic |
Official Title: | Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections |
Actual Study Start Date : | September 24, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: Rapid Turnaround Test
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
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Device: Cepheid Xpert CT/NG Rapid Turnaround Test
This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Other Name: GeneXpert Device: Polymerase chain reaction (PCR) This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Other Name: PCR |
Active Comparator: Usual Care
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
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Device: Polymerase chain reaction (PCR)
This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Other Name: PCR |
- Rate of Overtreatment with Antibiotics [ Time Frame: One year ]Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
- Length of Stay [ Time Frame: One year ]Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay in the Emergency Department.
- Test congruence [ Time Frame: One year ]Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in those subjects that have both performed (Experimental Group).
- Healthcare costs. [ Time Frame: One year ]Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
- Patient and provider satisfaction [ Time Frame: One year ]Evaluate patient and provider satisfaction with the 2 diagnostic groups.
- Need for additional healthcare [ Time Frame: One year ]Compare need for additional healthcare utilization between the groups.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Participant eligibility is not based on self-representation of gender identity. All participants in this study will receive a pelvic exam in the emergency department as well as a cervical swab for diagnostic testing. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female patients age 18-55
- Signs or symptoms consistent with sexually transmitted infection
- Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia
- Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation
- Provides informed consent
Exclusion Criteria:
- Signs of systemic infection
- Patient in whom the provider is unwilling to consider the result of the rapid turnaround test
- Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months
- Patients undergoing evaluation for sexual assault
- Patients that are known to be pregnant or express concern that they may be pregnant
- Incarcerated patients
- Students/Employees of the facility
- Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098394
Contact: Dana Beach, RN | 410-328-7635 | dbeach3@som.umaryland.edu |
United States, Maryland | |
University of Maryland Medical Systems | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: R. Gentry Wilkerson, MD 410-328-4237 gwilkerson@som.umaryland.edu |
Principal Investigator: | Richard G Wilkerson, MD | University of Maryland School of Medicine |
Publications:
Responsible Party: | Richard Gentry Wilkerson, Assistant Professor, University of Maryland, Baltimore |
ClinicalTrials.gov Identifier: | NCT03098394 |
Other Study ID Numbers: |
HP-00072766 |
First Posted: | March 31, 2017 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We do not plan on sharing any individual participant data with other researchers |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Rapid turnaround test RTAT Gonorrhea Chlamydia STI |
Infections Chlamydia Infections Gonorrhea Sexually Transmitted Diseases Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Sexually Transmitted Diseases, Bacterial Communicable Diseases Neisseriaceae Infections Disease Attributes Pathologic Processes |